Supraclavicular Brachial Plexus BlockNCT04216823
Perfusion Index as an Objective Measure for Supraclavicular Brachial Plexus Block in Pediatric Patients
An observational study of Supraclavicular Brachial Plexus Block, run by Tongji Hospital at 1 site in China.
Trial summary
The aim of the present study is to evaluate the effects of supraclavicular brachial plexus block using perfusion index in pediatric patients undergoing Upper limb surgery. Read more about this study
- Who is it for?
- Ages 1 month to 12 years
- Conditions the study is for
- Supraclavicular Brachial Plexus Block
- What is being tested?
- perfusion index
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2021to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: ASA physical status I-II,Age 1 month-12 year,Children undergoing Upper limb surgery.
Who may be able to join
- ASA physical status I-II
- Children undergoing Upper limb surgery.
- Parents' agreement.
Who cannot join
- Parents' refusal.
- Children with behavioral changes
- Children with physical developmental delay
- Children on treatment with sedative or anticonvulsant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Perfusion Index as an Objective Measure for Supraclavicular Brachial Plexus Block in Pediatric Patients
The aim of the present study is to evaluate the effects of supraclavicular brachial plexus block using perfusion index in pediatric patients undergoing Upper limb surgery.
Read the detailed description
The role of perfusion index in the prediction of peripheral block success was previously reported for infraclavicular brachial plexus block, axillary brachial plexus block, interscalene brachial plexus block, and supraclavicular brachial plexus in adult patients. The aim of the present study is to assess the effects of perfusion index on success of supraclavicular brachial plexus block in pediatric patients.
- Conditions
- Supraclavicular Brachial Plexus Block
- Being tested
- perfusion index
- Keywords
- perfusion index, supraclavicular brachial plexus block, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perfusion indexDevice
perfusion index in the prediction of peripheral block success was previously reported for infraclavicular brachial plexus block, axillary brachial plexus block, interscalene brachial plexus block, and supraclavicular brachial plexus in adult patients
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane Group | sevoflurane is used for anesthetic induction Receives: Device: perfusion index | |
| Propofol Group | intravenous anesthetic propofol is used for anesthetic induction Receives: Device: perfusion index |
What is being measured
The primary outcome is the main question the study is designed to answer.
perfusion index
Correlation between success of supraclavicular brachial plexus block and perfusion index
Measured: the time span between 1 day preoperative and 24 hours after surgery
Secondary outcomes (3)
mean arterial blood pressure
perioperative mean arterial blood pressure in mmHg
Measured: the time span between 1 day preoperative and 24 hours after surgery
heart rate
perioperative heart rate as beat/min
Measured: the time span between 1 day preoperative and 24 hours after surgery
PI ratio
Correlate between baseline PI and 10min after supraclavicular brachial plexus block
Measured: up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start6 Jul 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Supraclavicular Brachial Plexus BlockStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aijun xu, Tongji Hospital
- Investigators
- Hong Liu, Dr., Study chair, Huazhong university, Tongji medical college
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216823
- Sponsor's protocol ID
- PISP
- Status last verified
- Sep 2023
- First submitted
- 28 Dec 2019
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chu T, Zhou S, Peng T, Tao H, Chen H, Yan X, Xin Y, Tian Z, Wang J, Deng L, Xu A. Perfusion Index Predicts the Effectiveness of Supraclavicular Brachial Plexus Block in Children Under General Anesthesia: A Randomized Controlled Trial. Anesthesiol Res Pract. 2025 Feb 22;2025:5583145. doi: 10.1155/anrp/5583145. eCollection 2025.
PubMed 40026611Wang J, Deng L, Xu A. Evaluation of prediction effect of perfusion index for supraclavicular brachial plexus block in children: protocol for a randomized trial. Trials. 2022 Aug 4;23(1):629. doi: 10.1186/s13063-022-06597-y.
PubMed 35927745
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Perfusion Index as an Objective Measure for Supraclavicular Brachial Plexus Block in Pediatric Patients
- ClinicalTrials.gov ID
- NCT04216823
- Acronym / sponsor ID
- PISP
- Conditions
- Supraclavicular Brachial Plexus Block
- Keywords
- perfusion index, supraclavicular brachial plexus block, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 3 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to evaluate the effects of supraclavicular brachial plexus block using perfusion index in pediatric patients undergoing Upper limb surgery.
Detailed description
The role of perfusion index in the prediction of peripheral block success was previously reported for infraclavicular brachial plexus block, axillary brachial plexus block, interscalene brachial plexus block, and supraclavicular brachial plexus in adult patients. The aim of the present study is to assess the effects of perfusion index on success of supraclavicular brachial plexus block in pediatric patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane Group | – | Device: perfusion indexsevoflurane is used for anesthetic induction |
| Propofol Group | – | Device: perfusion indexintravenous anesthetic propofol is used for anesthetic induction |
Who may qualify
- Ages
- 1 month to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- ASA physical status I-II,Age 1 month-12 year,Children undergoing Upper limb surgery.
Key inclusion criteria (3 listed)
- ASA physical status I-II
- Children undergoing Upper limb surgery.
- Parents' agreement.
Key exclusion criteria (4 listed)
- Parents' refusal.
- Children with behavioral changes
- Children with physical developmental delay
- Children on treatment with sedative or anticonvulsant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| perfusion indexperfusion index in the prediction of peripheral block success was previously reported for infraclavicular brachial plexus block, axillary brachial plexus block, interscalene brachial plexus block, and supraclavicular brachial plexus in adult patients | Device | Propofol Group, Sevoflurane Group |
Primary outcome
perfusion index
Time frame: the time span between 1 day preoperative and 24 hours after surgery
Correlation between success of supraclavicular brachial plexus block and perfusion index
3 secondary outcomes
mean arterial blood pressure
Time frame: the time span between 1 day preoperative and 24 hours after surgery
heart rate
Time frame: the time span between 1 day preoperative and 24 hours after surgery
PI ratio
Time frame: up to 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Derived from this study: PubMed 40026611Chu T, Zhou S, Peng T, Tao H, Chen H, Yan X, Xin Y, Tian Z, Wang J, Deng L, Xu A. Perfusion Index Predicts the Effectiveness of Supraclavicular Brachial Plexus Block in Children Under General Anesthesia: A Randomized Controlled Trial. Anesthesiol Res Pract. 2025 Feb 22;2025:5583145. doi: 10.1155/anrp/5583145. eCollection 2025.
- Derived from this study: PubMed 35927745Wang J, Deng L, Xu A. Evaluation of prediction effect of perfusion index for supraclavicular brachial plexus block in children: protocol for a randomized trial. Trials. 2022 Aug 4;23(1):629. doi: 10.1186/s13063-022-06597-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Liu, Dr. study chair
Huazhong university, Tongji medical college
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Supraclavicular Brachial Plexus Block, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
perfusion index (time frame: the time span between 1 day preoperative and 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04216823, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.